SPIRIT MB
Received Mar 14, 2014
Report 2016150-2014-00023 · MDR key 3679839
Device
Generic name
Orthodontic Bracket, Plastic
Manufacturer
Ormco CorporationCatalog number
202-0069
Lot number
081351013
Product problems
- Nonstandard Device
- Device Markings/Labelling Problem
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
NO INJURIES WERE ASSOCIATED WITH THIS INCIDENT. THE DOCTOR NOTICED THE MARKING WAS IN THE WRONG AREA AND STOPPED USING THE DEVICE. PICTURES OF THE PRODUCT ALLEGED IN THIS INCIDENT CONFIRMED THAT THE IDENTIFICATION DOT IS LOCATED ON THE INCORRECT AREA OF THE BRACKET. A RETAIN SAMPLE OF THE PRODUCT WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.
Description of Event or Problem
A DEALER REPORTED THAT A DOCTOR'S OFFICE ALLEGED THAT SPIRIT MB IDENTIFICATION DOT IS LOCATED ON THE INCORRECT AREA OF THE BRACKET.
Additional Manufacturer Narrative
SYBRONENDO CORPORATION WAS INFORMED ON 04/14/2014 BY A DEALER REPRESENTATIVE THAT THE WRONG ITEM NUMBER AND DESCRIPTION WAS GIVEN ON THE INITIAL COMPLAINT REPORT. THE CORRECT ITEM NUMBER INVOLVED IN THE ALLEGED INCIDENT IS 202-0069 AND THE DESCRIPTION IS CHANNELS 21MM FILES.
Remedial action
- Recall